Trial Outcomes & Findings for Response Variability in Children With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT01238822)
NCT ID: NCT01238822
Last Updated: 2012-04-04
Results Overview
Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54 O - No ADHD symptoms 54 - Highest ADHD symptoms
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
96 participants
Primary outcome timeframe
end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.
Results posted on
2012-04-04
Participant Flow
Children were recruited through multiple community and clinical sources including schools and local practitioners to participate in a study of the effects of medication on cognitive functioning. Diagnostic status was determined using methodology similar to that employed by the Multimodal Treatment Study of ADHD (MTA Cooperative Group, 1999).
Participant milestones
| Measure |
All Participants
All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
|
|---|---|
|
Overall Study
STARTED
|
96
|
|
Overall Study
Received Placebo
|
93
|
|
Overall Study
Received Low Dosage
|
93
|
|
Overall Study
Received Medium Dosage
|
93
|
|
Overall Study
Received High Dosage
|
93
|
|
Overall Study
COMPLETED
|
93
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Participants
All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
|
|---|---|
|
Overall Study
COULD NOT SWALLOW PILLS
|
3
|
Baseline Characteristics
Response Variability in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
All Participants
n=96 Participants
All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
|
|---|---|
|
Age, Categorical
<=18 years
|
96 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
8.11 years
STANDARD_DEVIATION 1.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.Population: Intent to treat with imputation for missing data.
Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54 O - No ADHD symptoms 54 - Highest ADHD symptoms
Outcome measures
| Measure |
Placebo
n=96 Participants
placebo
|
Low Dosage
n=96 Participants
18 mg methylphenidate
|
Medium Dosage
n=96 Participants
36 mg methylphenidate if \>25 kg; 27 mg methylphenidate if \< 25 kg.
|
High Dosage
n=96 Participants
54 mg methylphenidate if \>25 kg; 36 mg methylphenidate if \< 25 kg.
|
|---|---|---|---|---|
|
Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items
|
26.54 Score
Standard Deviation 12.03
|
25 Score
Standard Deviation 12.73
|
18.94 Score
Standard Deviation 11.18
|
18.46 Score
Standard Deviation 11.68
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Low Dosage
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Medium Dosage
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
High Dosage
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=96 participants at risk
|
Low Dosage
n=96 participants at risk
Low dose: 18 mg methylphenidate
|
Medium Dosage
n=96 participants at risk
Medium Dosage: 36 mg methylphenidate
|
High Dosage
n=96 participants at risk
54 mg methylphenidate
|
|---|---|---|---|---|
|
Psychiatric disorders
Hallucination
|
0.00%
0/96
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
0.00%
0/96
|
Other adverse events
| Measure |
Placebo
n=96 participants at risk
|
Low Dosage
n=96 participants at risk
Low dose: 18 mg methylphenidate
|
Medium Dosage
n=96 participants at risk
Medium Dosage: 36 mg methylphenidate
|
High Dosage
n=96 participants at risk
54 mg methylphenidate
|
|---|---|---|---|---|
|
Psychiatric disorders
Parent reported tics
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
2.1%
2/96 • Number of events 2
|
|
Nervous system disorders
Parent-reported buccal-lingual movements
|
1.0%
1/96 • Number of events 1
|
0.00%
0/96
|
2.1%
2/96 • Number of events 2
|
2.1%
2/96 • Number of events 2
|
|
Nervous system disorders
Parent-reported picking at skin or fingers, nail-biting, or cheek chewing
|
3.1%
3/96 • Number of events 3
|
1.0%
1/96 • Number of events 1
|
3.1%
3/96 • Number of events 3
|
7.3%
7/96 • Number of events 7
|
|
Psychiatric disorders
Parent-reported worried/anxious
|
2.1%
2/96 • Number of events 2
|
3.1%
3/96 • Number of events 3
|
5.2%
5/96 • Number of events 5
|
9.4%
9/96 • Number of events 9
|
|
Nervous system disorders
Parent-reported dull, tired, listless
|
4.2%
4/96 • Number of events 4
|
3.1%
3/96 • Number of events 3
|
2.1%
2/96 • Number of events 2
|
7.3%
7/96 • Number of events 7
|
|
Nervous system disorders
Parent-reported headaches
|
0.00%
0/96
|
0.00%
0/96
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
|
Nervous system disorders
Parent-reported stomachache
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
|
General disorders
Parent-reported crabby, irritable
|
0.00%
0/96
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
Psychiatric disorders
Parent-reported tearful, sad, depressed
|
0.00%
0/96
|
0.00%
0/96
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
|
Psychiatric disorders
Parent-reported socially withdrawn
|
0.00%
0/96
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
2.1%
2/96 • Number of events 2
|
|
Psychiatric disorders
Parent-reported hallucinations
|
1.0%
1/96 • Number of events 1
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
Metabolism and nutrition disorders
Parent-reported loss of appetite
|
1.0%
1/96 • Number of events 1
|
0.00%
0/96
|
0.00%
0/96
|
2.1%
2/96 • Number of events 2
|
|
Psychiatric disorders
Parent-reported trouble sleeping
|
1.0%
1/96 • Number of events 1
|
3.1%
3/96 • Number of events 3
|
0.00%
0/96
|
1.0%
1/96 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place